No registrations found.
ID
Source
Brief title
Health condition
Vulvar cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The proportion of patients in whon sentinel and non-sentinel lymph nodes can be identified;
2. Difference in signal-to-background ratio between different injection groups.
Secondary outcome
1. Carrelation between fluorescent and radioactove nodes;
2. The correlation between the quantitative fluorescence signal and quantitative radioactive signal.
Background summary
Although sentinel lymph node procedure (SLNP) is regarded standard of care, the technique is not optimal and it requires involvement of ionizing radiation. Fluorescent imaging using near-infrared probes is an innovative technique to directly visualize lymphatic pathways and lymph nodes. In previous experiment we succesfully identifies SLNs with fluorescent imaging. In this study, a combined fluorescent and radioactive probe is used for SLN identification.
Study objective
ICG combined with 99Tc-Nanocoll can be used as fluorescent tracer in sentinel lymph node mapping in vulvar cancer patients.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
Standard SLNP will be performed. One day before surgery or the day of surgery. 99TC-Nanocoll-ICG will be injected and lymphatic pathways and lymph nodes will be visualized non-invasively and percutaneously using our experimental camerasystem during surgery.
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Inclusion criteria
Vulvar cancer patients planned to undergo a sentinel lymph node procedure.
Exclusion criteria
1. History of allergy to iodine, shellfish, indocyanine green or human serum albumin;
2. Pregnancy;
3. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3679 |
| NTR-old | NTR3849 |
| Other | METC Leiden : P09.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |